Europe — EMA
Nipfilan (Nintedanib)
GNH USA supplies Nipfilan (Nintedanib), a tyrosine kinase inhibitor for idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung
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What is Nintedanib?
Nintedanib, the active ingredient in Nipfilan, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is indicated for the treatment of idiopathic pulmonary fibrosis, systemic sclerosis‑associated interstitial lung disease, and non‑small cell lung cancer in adult patients.
GNH USA supplies Nipfilan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The company adheres to stringent quality standards and provides regulatory‑approved batches to meet global demand. Clients benefit from reliable logistics, comprehensive documentation, and ongoing pharmacovigilance support.
What is Nintedanib used for?
Nintedanib is used to manage fibrotic lung disorders and certain cancers by inhibiting pathways that drive fibroblast proliferation and angiogenesis.
- Idiopathic pulmonary fibrosis: slows disease progression and reduces decline in lung function. - Systemic sclerosis‑associated interstitial lung disease: improves lung capacity and delays worsening. - Non‑small cell lung cancer: used in combination regimens to inhibit tumor growth.
What are the side effects of Nintedanib?
Nintedanib may cause a range of adverse reactions that vary in frequency and severity.
Common Side Effects: - Diarrhea: frequent loose stools, often mild to moderate. - Nausea: feeling of sickness, may be accompanied by loss of appetite. - Vomiting: occasional episodes, usually self‑limiting. - Decreased appetite: reduced desire to eat, can affect weight. - Abdominal pain: discomfort or cramping in the stomach area. - Elevated liver enzymes: increased ALT/AST levels on laboratory testing.
Serious or Rare Side Effects: - Severe liver injury: jaundice, hepatitis, or hepatic failure. - Arterial thromboembolism: blood clots in arteries leading to stroke or heart attack. - Major bleeding: gastrointestinal or intracranial hemorrhage. - Hypertension: significant rise in blood pressure requiring medical intervention. - Perforated bowel: rare but life‑threatening intestinal rupture. - Severe infections: opportunistic infections requiring prompt treatment.
What precautions apply to Nintedanib?
Before initiating therapy, clinicians should assess patient suitability and monitor for potential complications. - Liver function monitoring: obtain baseline tests and repeat periodically during treatment. - Cardiovascular assessment: evaluate risk of arterial thrombosis and control hypertension. - Bleeding risk: avoid concurrent use of strong anticoagulants or antiplatelet agents without careful supervision. - Pregnancy and lactation: safety not established; avoid use in pregnant or nursing women. - Store at ambient temperature below 25°C: keep in the original pack, protect from moisture and light.
What does Nintedanib interact with?
Nintedanib interacts with several drug classes that may alter its exposure or increase adverse events.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole): may raise nintedanib plasma levels. - Anticoagulants (e.g., warfarin): heightened risk of serious bleeding. - Antiplatelet agents (e.g., aspirin, clopidogrel): increased bleeding tendency.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin): modest increase in exposure. - P‑gp inhibitors (e.g., verapamil, amiodarone): may elevate drug concentrations. - Diuretics: potential for dehydration, monitor renal function and electrolytes.



